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| Medical Policy: | I-183-002 |
| Topic: | Voretigene Neparvovec-rzyl (Luxturna) |
| Section: | Injections |
| Effective Date: | July 1, 2018 |
| Issue Date: | July 2, 2018 |
| Last Reviewed: | March 2018 |
Voretigene neparvovec-rzyl (Luxturna™) is an adeno-associated virus vector-based gene therapy indicated for the treatment of patients with confirmed biallelic retinal pigment epithelium-specific 65 kDa protein (RPE65) mutation-associated retinal dystrophy. The RPE65 gene provides instructions for making a protein that is essential for normal vision. The RPE65 protein is produced in a thin layer of cells at the back of the eye called the retinal pigment epithelium (RPE). This cell layer supports and nourishes the retina, which is the light-sensitive tissue that lines the back of the eye. |
This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.
| Policy Position Coverage is subject to the specific terms of the member’s benefit plan. |
Voretigene neparvovec-rzyl (Luxturna) may be considered medically necessary for the treatment of biallelic RPE65 mutation-associated retinal dystrophy in individuals three (3) years of age up to and including 65 years of age when ALL of the following criteria are met:
- Confirmed diagnosis of inherited retinal disease caused by RPE65 gene mutations demonstrated by documented mutation in both copies of the RPE65 gene; and
- Voretigene neparvovec-rzyl (Luxturna) is prescribed by a retinal specialist; and
- Individual has sufficient viable retinal cells as determined by the treating physician and assessed via optical coherence tomography (OCT) imaging and/or ophthalmoscopy, demonstrating EITHER of the following:
- Retinal thickness on spectral domain optical coherence tomography is greater than 100 microns within the posterior pole; or
- Clinical exam, noting greater than or equal to three (3) disc areas of retina without atrophy or pigmentary degeneration within the posterior pole; and
- No intraocular surgery in the past six (6) months; and
- Individual is not currently pregnant or breastfeeding; and
- Patient has not previously received RPE65 gene therapy in intended eye.
Note: Coverage for voretigene neparvovec-rzyl (Luxturna) is limited to one subretinal injection per eye, administered on separate days within a close interval, but no fewer than six (6) days apart (6-18 days per available body of evidence).
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Voretigene neparvovec-rzyl (Luxturna) is considered experimental/investigational for any other indications. Scientific evidence does not support its efficacy or safety for any other indications than those listed on this policy. |
NOTE: Dosage recommendations per FDA label. |
| Place of Service: Inpatient/Outpatient |
Experimental/Investigational (E/I) services are not covered regardless of place of service.
| The policy position applies to all commercial lines of business |
| Denial Statements |
Services that do not meet the criteria of this policy will be considered experimental/investigational (E/I). A network provider can bill the member for the experimental/investigational service. The provider must give advance written notice informing the member that the service has been deemed E/I. The member must be provided with an estimate of the cost and the member must agree in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.
| Outpatient HCPCS (C Codes) |
| C9032 |
| Links |
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Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.
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If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295, TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.
You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:
U.S. Department of Health and Human Services
200 Independence Avenue, SW
Room 509F, HHH Building
Washington, D.C. 20201
1-800-368-1019, 800-537-7697 (TDD)
Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.
Insurance or benefit/claims administration may be provided by Highmark, Highmark Choice Company, Highmark Coverage Advantage, Highmark Health Insurance Company, First Priority Life Insurance Company, First Priority Health, Highmark Benefits Group, Highmark Select Resources, Highmark Senior Solutions Company or Highmark Senior Health Company, all of which are independent licensees of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield plans.
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